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publicDanish Medicines Agency · Denmark · Updated Jun 25, 2026

IB template for cell therapy products

Urgency: High

Utilize the IB template provided for cell therapy products in clinical trial applications, available under the 'Special Product Areas' section of the Danish Medicines Agency's website.

Inspection ReadinessRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, PV Quality Lead
verifiedRegulatory action: Template
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